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Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861950
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : January 25, 2023
Sponsor:
Collaborators:
Stanford University
Dartmouth-Hitchcock Medical Center
Northwestern University
Boston Children's Hospital
Children's Medical Center Dallas
University of Mississippi Medical Center
University of New Mexico
The University of Texas Health Science Center, Houston
Oregon Health and Science University
Joe DiMaggio Children's Hospital
University of Michigan
Children's National Health System
University of Wisconsin, Madison
University of Iowa
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.

Condition or disease Intervention/treatment Phase
Hypospadias Urethrocutaneous Fistula Drug: Caudal block with ropivacaine Drug: penile nerve block with bupivacaine Phase 4

Detailed Description:

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:

There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.

The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
Drug Information available for: Bupivacaine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Caudal block
Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
 Drug: Caudal block with ropivacaine
Patients in this arm will receive a caudal block with ropivacaine
Active Comparator: Penile Nerve Block
Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.
 Drug: penile nerve block with bupivacaine
Patients in this arm will receive a penile block with bupivacaine


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of urethrocutaneous fistula [ Time Frame: 1 year ]
    Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.


Secondary Outcome Measures :
  1. Degree of efficacy of caudal block [ Time Frame: 1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery ]
    Blocks will be graded for efficacy using the following scale: Successful, Probably Successful, Probably Failed, or Failed.

  2. Degree of pain [ Time Frame: 1 hour after arrival in PACU post surgery ]
    Patients will have pain scores determined using the modified FLACC score (Face, Legs, Activity, Cry, Consolability) 1 hour after arrival in the PACU

  3. Need for supplemental analgesics [ Time Frame: 1 hour after arrival in PACU post surgery ]
    Administration of opioid in the first postoperative hour will be determined


Eligibility Criteria
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Ages Eligible for Study:   4 Months to 2 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.

Exclusion Criteria:

  • prior hypospadias surgery,
  • proximal or penoscrotal hypospadias,
  • abnormal caudal anatomy or spinal dysraphism,
  • cyanotic congenital heart disease,
  • infection or rash at the block injection site.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861950


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Stanford University
Dartmouth-Hitchcock Medical Center
Northwestern University
Boston Children's Hospital
Children's Medical Center Dallas
University of Mississippi Medical Center
University of New Mexico
The University of Texas Health Science Center, Houston
Oregon Health and Science University
Joe DiMaggio Children's Hospital
University of Michigan
Children's National Health System
University of Wisconsin, Madison
University of Iowa
Investigators
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Principal Investigator: Megan Brockel, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02861950    
Other Study ID Numbers: 15-2343
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
hypospadias
caudal
urethrocutaneous fistula
penile nerve block
Additional relevant MeSH terms:
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Hypospadias
Fistula
Pathological Conditions, Anatomical
Penile Diseases
Urogenital Abnormalities
Congenital Abnormalities
Bupivacaine
 Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents